Camrelizumab in Combination With Chemotherapy or Apatinib Mesylate as First-Line Treatment for R/… (NCT05156970) | Clinical Trial Compass
CompletedPhase 2
Camrelizumab in Combination With Chemotherapy or Apatinib Mesylate as First-Line Treatment for R/M HNSCC
China81 participantsStarted 2021-06-24
Plain-language summary
This study is the first clinical study of first-line treatment of head and neck squamous cell carcinoma with drugs targeting VEGF signaling pathway combined with PD-1 inhibitors in China, which explores the new combination therapies urgently needed in clinical practice and lays a foundation for subsequent studies, with important scientific research significance and clinical value.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Newly diagnosed recurrent or metastatic head and neck squamous cell carcinoma which is histologically or cytologically confirmed, and unable to be cured by local treatment (the primary site of the tumor is the oropharynx, oral cavity, hypopharynx and larynx), recurrence or metastasis stage did not receive any anti-tumor systemic therapy (allowed as part of the treatment of locally advanced tumors, and it has been more than 6 months from the end of treatment to signing the informed consent);
✓. ECOG score of 0 or 1;
✓. At least one measurable lesion according to RECIST1.1 criteria.
✓. Tumor tissue with PD-L1 detection (paraffin specimens or fresh tumor tissue within 2 years) can be provided; Patients with Oropharyngeal cancer should provide P16 detection status by using IHC method;
✓. Patients with a history of brain/meningeal metastasis must be treated with local therapy (surgery/radiotherapy) before the start of the study, and clinically stable for at least 3 months (corticosteroids are allowed before the first dose of the study drug, but need to be discontinued 2 weeks before the start of the study drug); The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up.
Exclusion criteria
✕. Progression within 6 months after systemic treatment for locally advanced head and neck squamous cell carcinoma;
✕. Previous history of primary tumor of nasopharyngeal carcinoma;
✕. Intolerable to platinum-based therapy;
✕
What they're measuring
1
Overall Survival (OS) in All Participants
Timeframe: 12 months
Trial details
NCT IDNCT05156970
SponsorShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
. Previous treatment with platinum-based regimen and disease progression;
✕. Patients who participated in or were participating in other drug/therapy clinical trials 4 weeks before the first dose of study drug;
✕. Patients who underwent major surgery or had not recovered from the side effects of this surgery; Patients who has accepted live vaccination, immunotherapy, or patients who underwent radiotherapy within 2 weeks;
✕. Patients who received any other anti-tumor treatment;
✕. Patients who are using immunosuppressive agents, or systemic hormone therapy to achieve the purpose of immunosuppression (dose \> 10 mg/day prednisone or other effective hormones), and continue to use 2 times before enrollment;